The following data is part of a premarket notification filed by Innovacyn, Inc. with the FDA for Puracyn(r) Plus Duo-care(tm) Antimicrobial Wound & Skin Hydrogel, Puracyn(r) Plus Antimicrobial Hydrogel Professional Formula.
| Device ID | K150799 |
| 510k Number | K150799 |
| Device Name: | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula |
| Classification | Dressing, Wound, Drug |
| Applicant | INNOVACYN, INC. 3546 N. RIVERSIDE AVE. Rialto, CA 92377 |
| Contact | Victor Torcat Mallen |
| Correspondent | Roshana Ahmed OptumInsight (Canada) Inc. 4 Innovation Drive Dundas, CA L9h 7p3 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-03-26 |
| Decision Date | 2015-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479232488 | K150799 | 000 |
| 10818582012789 | K150799 | 000 |
| 10818582011805 | K150799 | 000 |
| 10818582012420 | K150799 | 000 |
| 10818582012802 | K150799 | 000 |
| 10818582010938 | K150799 | 000 |
| 40612479232486 | K150799 | 000 |